BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A

    Recall: Z-2126-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2126-2026
    Event ID
    98642
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    January 7, 2026
    Classification Date
    May 7, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189; 5) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189A

    Reason

    Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

    Code Info

    1) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21ABJ542; 2) DYKMBNDL106, UDI-DI: 10193489479294(each), 40193489479295(case), Lot Number: 21BBG085; 3) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 21KLA631; 4) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22ALA713; 5) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22BLB059; 6) DYKMBNDL106A, UDI-DI: 10193489880816(each), 40193489880817(case), Lot Number: 22CLA049; 7) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS539; 8) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21ABS540; 9) DYKMBNDL188, UDI-DI: 10193489478549(each), 40193489478540(case), Lot Number: 21CBS043; 10) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21ABI996; 11) DYKMBNDL189, UDI-DI: 10193489478457(each), 40193489478458(case), Lot Number: 21BBG092; 12) DYKMBNDL189A, UDI-DI: 10193489880823(each), 40193489880824(case), Lot Number: 21JLA521

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    59 units